PAPZIMEOS

Precigen, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 12, 2025
Approval ID: 103db7f1-8540-4bea-935e-217d69e7aa01
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PAPZIMEOS™ safely and effectively. See full prescribing information for PAPZIMEOS. PAPZIMEOS (zopapogene imadenovec-drba) suspension for subcutaneous injectionInitial U.S. Approval: 2025

Quick Stats

Total Products1

Labelers1

Label Sections14

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.